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Alternatives to the Gluten Free Diet: Are We There Yet? By Michelle Pietzak, MD

Scott Adams

In 1994 I was diagnosed with celiac disease, which led me to create Celiac.com in 1995. I created this site for a single purpose: To help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives. Celiac.com was the first site on the Internet dedicated solely to celiac disease. In 1998 I foundedÂ The Gluten-Free Mall, Your Special Diet Superstore!, and I am the co-author of the book Cereal Killers, and founder and publisher of Journal of Gluten Sensitivity.

Celiac.com 08/29/2007 - The XII International Celiac Disease Symposium,
proudly hosted by the Celiac Disease Center at Columbia University,
featured presentations from researchers from all over the globe. The
last session of the scientific portion of the symposium, entitled “Non-Dietary
Therapies”, was full of controversy and fireworks. Talks given
by Drs. Khosla, Gray, Paterson, Anderson and Mitea all revealed that
potential alternatives to the gluten free diet are now being aggressively
pursued. Several groups have even spun off from pharmaceutical companies
to raise funds to test these alternatives in patient trials. However,
several questions remain. How close are we to a “pill” or
“vaccine” to treat or prevent celiac disease? And do we
even need, or more importantly, WANT them, given that the diet is safe
and effective?

Any alternative therapy for celiac disease must be at
least as safe as the gluten-free diet, which, if done correctly, has NO
side-effects. So the bar is raised very high. An alternative must offer
great medical benefit to celiac patients without causing any medical harm.
It is also unclear how, exactly, these new therapies will be implemented.
Can they treat existing celiac disease? Will they prevent those at increased
risk for the disease (such as siblings) from having symptoms? Will these
medications allow celiac patients to ingest as much gluten as they want,
or will they just take away the fear of contamination when eating questionable
foods? What follows is a summary of several important points raised by
some of these speakers in regard to the research that their center is
doing in this area of “alternative therapies for celiac disease.

Two groups discussed their research on what has commonly
become known as “the celiac pill”. The idea behind the “pill”
is somewhat similar to the idea of taking a lactase enzyme supplement
to digest the milk sugar lactose (if you are lactose intolerant). However,
digesting the proteins that trigger the immune reaction in celiac disease
is much more complex than digesting the simple sugar found in dairy products.
The small fragments of the gluten proteins from wheat, rye and barley,
which stimulate the immune system in someone with celiac disease, contain
a large quantity of an amino acid called proline. The stomach and pancreatic
enzymes in humans have difficulty digesting the fractions where these
prolines are located, making the gluten highly resistant to complete digestion.
The idea behind the “celiac pill” is to provide enzymes to
break down the gluten into smaller fragments which will not be recognized
by a celiac patient’s immune system. Therefore, theoretically, gluten
would not cause an immune reaction and could be safely eaten.

Dr. Gary Gray, an adult gastroenterologist working at
Stanford University in California, addressed this issue in his presentation
“Oral Enzyme Therapy”. Their study looked at 20 biopsy-proven
celiacs in remission (without symptoms) who received orange juice with
either gluten or gluten pre-treated with a special enzyme (abbreviated
PEP, for prolyl endopeptidase). Each patient consumed a low dose of gluten
daily, 5 grams, which is equivalent to one slice of bread. The patients
completed a daily symptom questionnaire, and had urine and stool tests
of to measure intestinal damage. The researchers concluded that pretreatment
of gluten with PEP avoided the development of fat or carbohydrate malabsorption
in the majority of those patients who, after a 2-week gluten challenge,
developed fat or carbohydrate malabsorption. The PEP enzyme needs to be
investigated further in larger trials of celiac patients.

Cristina Mitea, working with Dr. Fritz Koning at Leiden
University in The Netherlands, also presented some data using similar
technology, entitled “Enzymatic degradation of gluten in a GI-tract
model”. This group published in 2006 that the above described PEP
enzyme may not work optimally in the celiac patient, since it is not active
at low stomach pH. The PEP enzyme may also be broken down by pepsin, a
digestive enzyme in the stomach, before it reaches the small bowel where
gluten causes the most damage. Given these facts, this group of researchers
characterized a prolyl endoprotease enzyme, derived from the fungus Aspergillus
niger, abbreviated AN-PEP. The AN-PEP enzyme, according to some publications,
has been shown to work at stomach pH while resisting pepsin digestion.
In the lab, the AN-PEP was able to degrade intact gluten as well as small
fragments of gluten, including those that stimulate the immune system
in patients with celiac disease. It also appeared to act within minutes,
which is 60 times faster than PEP. This is particularly important, as
ingested gluten will leave the stomach to enter the small bowel within
1 to 4 hours after being eaten. These researchers state that this enzyme
is very stable, and could be produced at low cost at food-grade quality
in an industrial setting. However, it has not yet been tested in human
clinical studies.

Dr. Michelle Pietzak, “The Gluten Free MD”
is an Assistant Professor of Clinical Pediatrics at the University of
Southern California Keck School of Medicine. She sees patients at Childrens
Hospital Los Angeles and Los Angeles County Women’s and Children’s
Hospital. With New Era Productions, she has recently released an audio
celiac disease set as well as a 2 disc DVD set about celiac disease and the gluten
free diet, available at www.glutenfreemd.com.

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There are several companies the tout a product for gluten sensitivities and you need to be cautious as they mostly all use DPPIV which is used in the majority of cases for Lactose intolerance. There have not been any clinical studies on the ANPEP yet and as far as I know it is not commercially available.